Health
Children with autism may see speech improvements with off-label prescription drug
An off-label prescription drug has been shown to help some non-verbal children with autism discover the ability to speak.
The drug, leucovorin, is a prescription vitamin that functions similarly to folic acid, helping to restore folate levels in patients who may have difficulty absorbing or using it, according to Katy Dubinsky, a New York pharmacist and the CEO and co-founder of Vitalize, a private supplement company.
“Leucovorin is FDA-approved to reduce the toxic effects of high-dose methotrexate in cancer treatment and to prevent or treat certain types of anemia caused by folate deficiency,” Dubinsky told Fox News Digital.
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While leucovorin isn’t prescribed for the treatment of autism, some families have found that its off-label use has led to significant improvements in autistic children’s communication skills, experts say.
Richard E. Frye, M.D., PhD, a behavioral child neurologist in Arizona, has studied the drug in his research of experimental treatments for children with autism spectrum disorder.
An off-label prescription drug has been shown to help some non-verbal children with autism discover the ability to speak. (iStock)
“Leucovorin is a special form of vitamin B9 that is water-soluble and does not build up in your body,” he told Fox News Digital.
“Folates have been found to be safe long-term for many years and that is why we supplement our food with folate.”
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The main benefit of leucovorin for children with autism is improvement in language, Frye said, but other advantages may include enhanced social function, reduced repetitive behaviors and stronger attention skills.
“Our goal is to get leucovorin approved by the FDA for autism so it can be widely prescribed to children as one of the first treatments once they are diagnosed.”
“We do find that leucovorin helps a substantial number of children with autism,” he said. “Language is one of the most obvious things, so that is what we measured in our clinical trial.”
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News’ senior medical analyst, also spoke to Fox News Digital about why the drug may have this positive impact.
While leucovorin isn’t prescribed for autism treatment, some families have found that its off-label use has led to significant improvements in the communication skills of children with autism. (iStock)
“Central folate deficiency is a lack of folate in the brain, which can interfere with neurological function,” he said. “A high percentage of children with autism spectrum disorder have been found to have antibodies against folic receptor alpha in the brain.”
Leucovorin is converted to folate in the brain by a different pathway, Siegel said.
“Small studies are showing that it improves neurological function and communication skills in kids with ASD, but larger studies need to be done.”
Experts urge caution
The fact that leucovorin has already been used long-term helps to reduce the associated risk, according to doctors.
“One of the advantages of using leucovorin is that it has been used for decades to protect the body from the effects of chemotherapy, so we know what dose to use and any side effects it may produce,” Frye told Fox News Digital.
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However, some children do become “extremely hyperactive,” do not respond to leucovorin and end up needing alternative treatments, the doctor noted.
It’s important for families to work with a medical professional when exploring the use of leucovorin for autism, he advised.
The drug leucovorin is a prescription vitamin that functions similarly to folic acid, helping to restore folate levels in patients who may have difficulty absorbing or using it, according to a pharmacist. (iStock)
“Leucovorin is given at much higher doses than regular vitamins, so it’s very important to work with a doctor knowledgeable in how to prescribe it,” Frye said.
“It is important to test the patient for abnormalities in the folate pathway, such as the folate receptor autoantibody, so we know that they are a candidate for this medication.”
While leucovorin is available in the pharmacy, Frye noted that some children need a compounded form because they are sensitive to some of the additives in commercial products.
“Our goal is to get leucovorin approved by the FDA for autism so it can be widely prescribed to children as one of the first treatments once they are diagnosed,” he said.
Frye pointed out that there is “no magic bullet” for autism, with many children benefiting from a combination of multiple treatments. (iStock)
Dubinsky agreed that physicians may prescribe the “widely used and well-tolerated drug” for autism treatment based on their “clinical judgment and emerging evidence,” but she also stressed the importance of clinical trials.
“While doctors can prescribe leucovorin now, FDA approval would provide stronger medical backing, making it a recognized treatment rather than just an off-label option,” she told Fox News Digital.
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“This could lead to insurance coverage, standardized dosing guidelines and broader acceptance in the medical community.”
Siegel added that leucovorin is a “safe drug” and should be considered for large-scale use based on the findings of recent research.
‘No magic bullet’
Frye pointed out that there is “no magic bullet” for autism, with many children benefiting from a combination of multiple treatments.
“It is unlikely that leucovorin will be used alone — it must be used with behavioral and speech therapy,” he said. “We believe that leucovorin can improve outcomes for these therapies.”
“There is little evidence to suggest that the benefits observed in this individual case can be generalized to the broader autistic community.”
Andy Shih, PhD, chief science officer of Autism Speaks in New York, noted that every child’s experience with autism is unique.
“There is little evidence to suggest that the benefits observed in this individual case can be generalized to the broader autistic community,” he told Fox News Digital.
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“While some small studies have explored leucovorin as a potential treatment for people with autism, larger controlled clinical trials are needed to determine its efficacy and safety. We urge families to consult with their doctors before considering off-label treatments.”
Dubinsky added that if larger studies confirm leucovorin’s effectiveness, it could become a more accessible treatment for children with autism who may benefit from it.
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As colorectal cancer (CRC) is now the leading cause of cancer death in adults under 50, a new report reveals some surprising shifts in the incidence of the disease.
Although rates of CRC have been declining among seniors, those 65 and under are facing a rise in diagnoses, according to a report titled Colorectal Cancer Statistics, 2026, from the American Cancer Society.
Adults 65 and younger comprise nearly half (45%) of all new colorectal cancer cases — a significant increase from 27% in 1995, states the report, which was published in CA: A Cancer Journal for Clinicians.
The disease is rising fastest among adults 20 to 49 years old, at a rate of 3% per year.
Colorectal cancer is now the leading cause of cancer death in adults under 50. (iStock)
Among adults 50 and under, 75% of colorectal cancers are diagnosed at an advanced stage. Half of the diagnoses in that age range are made between the ages of 45 and 49. Although that age group is eligible to receive routine screenings, just 37% do so.
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The report also revealed that rectal cancer is on the rise, now accounting for about one-third (32%) of all CRC cases — an increase from 27% in the mid-2000s.
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“After decades of progress, the risk of dying from colorectal cancer is climbing in younger generations of men and women, confirming a real uptick in disease because of something we’re doing or some other exposure,” said Rebecca Siegel, senior scientific director, surveillance research at the American Cancer Society and lead author of the report, in a press release.
Among adults 50 and under, 75% of colorectal cancers are diagnosed at an advanced stage. Half of the diagnoses in that age range are made between the ages of 45 and 49. (iStock)
“We need to redouble research efforts to understand the cause, but also circumvent deaths through earlier detection by educating clinicians and the general public about symptoms and increasing screening in people 45-54 years.”
It is projected that 158,850 new cases of colorectal cancer will be diagnosed this year, and that the disease will cause 55,230 deaths, per the report.
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More than half of CRC cases can be linked to high-risk behaviors, the researchers said. Those include lack of nutrition, high alcohol consumption, smoking, lack of exercise and obesity.
“These findings further underscore that colorectal cancer is worsening among younger generations and highlight the immediate need for eligible adults to begin screening at the recommended age of 45,” said Dr. William Dahut, chief scientific officer at the American Cancer Society.
When the disease is caught at a local (early) stage, the five-year survival rate is 95%. (iStock)
“The report also shines a light on the crucial importance of continued funding for research to help discover new therapies to treat the disease and advance patient care.”
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When the disease is caught at a local (early) stage, the five-year survival rate is 95%, the report stated.
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A new study suggests that middle-aged men may be more vulnerable to faster biological aging, potentially linked to exposure to “forever chemicals.”
The research, published in the journal Frontiers in Aging, examined how perfluoroalkyl and polyfluoroalkyl substances, more commonly known as PFAS, could impact aging at the cellular level.
PFAS are synthetic chemicals commonly used in nonstick cookware, food packaging, water-resistant fabrics and other consumer products, the study noted.
Their chemical structure makes them highly resistant to breaking down, allowing them to accumulate in water, soil and the human body.
Chinese researchers analyzed blood samples from 326 adults enrolled in the U.S. National Health and Nutrition Examination Survey between 1999 and 2000.
A new study suggests that middle-aged men could face accelerated biological aging at the cellular level due to exposure to PFAS. (iStock)
The researchers measured levels of 11 PFAS compounds in participants’ blood and used DNA-based “epigenetic clocks” — tools that analyze chemical changes to DNA to estimate biological age — to determine how quickly their bodies were aging at the cellular level, the study stated.
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Two compounds, perfluorononanoic acid (PFNA) and perfluorooctanesulfonamide (PFOSA), were detected in 95% of participants.
Higher concentrations of those chemicals were associated with faster biological aging in men of certain age groups, but not in women.
“People should not panic.”
The compounds most strongly linked to accelerated aging were not the PFAS chemicals that typically receive the most public attention, the researchers noted.
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“The associations were strongest in adults aged 50 to 64, particularly in men,” Dr. Xiangwei Li, professor at Shanghai Jiao Tong University School of Medicine and the study’s corresponding author, told Fox News Digital.
“While this does not establish that PFAS cause aging, it suggests that these widely present ‘forever chemicals’ may be linked to molecular changes related to long-term health and aging.”
The study found that two of the compounds were detected in 95% of participants, and higher levels were linked to faster biological aging in men ages 50–64. (iStock)
Midlife may represent a more sensitive biological period, when the body becomes more vulnerable to age-related stressors, according to the researchers.
Lifestyle factors, such as smoking, may influence biological aging markers, potentially increasing vulnerability to environmental pollutants.
While Li said “people should not panic,” she does recommend looking for reasonable ways to reduce exposure.
That might mean checking local drinking water reports, using certified water filters designed to reduce PFAS, and limiting the use of stain- or grease-resistant products when alternatives are available.
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Meaningful reductions in PFAS exposure will likely depend on broader regulatory action and environmental cleanup efforts, Li added.
The researchers noted that midlife could be a particularly sensitive stage, when the body is more susceptible to stressors associated with aging. (iStock)
Study limitations
The researchers outlined several important limitations of the research, including that the findings show an association, but do not prove that PFAS directly causes accelerated aging.
“The study is cross-sectional, meaning exposure and aging markers were measured at the same time, so we cannot determine causality,” Li told Fox News Digital.
The study was also relatively small, limited to 326 adults age 50 or older, which means the findings may not apply to younger people or broader populations.
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Researchers measured PFAS levels using data collected between 1999 and 2000, and today’s exposure patterns may differ.
Li added that while PFAS is known to persist in the environment and the body, these results should be validated through larger, more recent studies that follow participants over time.
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